Volume 1 / Part 1 — FOREWORD (continued 9)

It would be hard to find better examples of mischievous proprietary medicines than these two products of the Micajah Company. “Twins of Efficiency,” they are called in an advertising pamphlet. The composition is not stated. A physician using the “twins” does so absolutely in the dark. To him they are secret preparations. He is encouraged to use them in a great variety of conditions in which other drugs are much more useful. Inevitably, physicians using them will be likely to overlook, or pass over, new growths, specific infections and diseases that require radical remedial measures.

In addition to misleading and exaggerated claims, there is a reference to a report from the usual “well-known and reliable bacteriological laboratory.” The excerpts published from this report of an unnamed laboratory are sufficiently vague to incriminate no one.

From time to time it is worth while to emphasize facts regarding proprietary medicines that while obvious are sometimes forgotten. For this reason attention is directed to Micajah’s Uterine Wafers and Micajah’s Suppositories.—(From The Journal A. M. A., Nov. 29, 1919)

ALKALITHIA

Report of the Council on Pharmacy and Chemistry

Alkalithia was introduced at a time when it was believed that the administration of lithium salts served to remove uric acid from the system. The product was considered by the Council in 1906, and found ineligible for New and Non­official Remedies. No report, however, was published at that time.

Because of inquiries received, the Council examined the current claims for Alkalithia, and authorized publication of the report which appears below.

W. A. Puckner, Secretary.

Keasbey and Mattison Company’s Effervescent Alkalithia is sold with the following statement of composition:

“Each dose or heaping teaspoonful contains 1 grain of Caffeine, 10 grains each of Bi-carbonates of soda and potash, and 5 grains of Carbonate of Lithia.”

The A. M. A. Chemical Laboratory reports that Alkalithia is an effervescent mixture which contains alkaline carbonates and bicarbonates together with caffein, free tartaric acid and free citric acid. The major portion of the alkali carbonates and bicarbonates is converted into citrates and tartrates when the preparation is dissolved in water—as is done before it is taken. An excess of alkali is present, however, as the solution has an alkaline reaction. Each “heaping teaspoonful” (which was found to be about 4.85 Gm.) contains about 0.044 Gm. of caffein (the manufacturers claim 0.0648 Gm. per heaping teaspoonful). As taken, Alkalithia, therefore, represents caffein in a solution of alkali tartrate, citrate and bicarbonate containing free carbonic acid. If it is assumed that all of the tartrate and citrate in Alkalithia is converted into carbonate in the organism, a “heaping teaspoonful” of Alkalithia would represent about 2.9 Gm. of sodium bicarbonate. This assumption is, however, not correct, for it is known that tartrates are not completely converted into carbonates in the organism.

According to the label on the bottle, this mixture of caffein and alkali salts is “a common sense remedy for the relief and treatment of conditions dependent upon perverted metabolism as manifested by neuralgic, rheumatic, cardiac and renal symptoms.” Wrapped with a trade package is a circular in which is discussed the “uric acid diathesis” as “a cause of Rheumatism in its various forms, Calculus, Gravel and Inflammation of the Bladder and Kidneys, Asthma, Hay Fever, Catarrh, Quinsy and Bronchitis, Eczema, Hives, Itching and Burning of the Skin, Palpitation of the Heart and Cold Hands and Feet, Dizziness, Mental Depression, Melancholia, Neuralgia, Chorea, Hysteria, Numbness and a great variety of purely nervous symptoms.” The arguments for the use of Alkalithia as “a safe and scientific treatment for the uric acid diathesis” found in the circular constitute an indirect appeal to the laity (conflict with Rule 4).

In the circular matter sent direct to the physicians, Keasbey and Mattison claim that in rheumatism, Alkalithia is prescribed by the medical profession more often than any other remedy. The claim is made that, “In five minutes the urine will be discolorized and analysis will show it to be loaded with urates.” The manufacturers further assert:

“You can change the character of the urinary secretion in a few minutes completely” by Alkalithia, and “In nine cases out of ten, when the doctor prescribes ‘Alkalithia’ his patient greatly improves, or gets well.”

The firm advises that “Renal Insufficiency” be determined by the old method of multiplying the ounces of urine in twenty-four hours by the last two numbers of the specific gravity, adding 10, which gives the number of grains of solids excreted in the twenty-four hours. If this is low, no matter what the cause, they advise Alkalithia, “that ideal eliminant.”

The Council declared Alkalithia inadmissible to New and Non­official Remedies because the claims made on the label and the circular accompanying the trade package lead the public to its detriment to depend on this preparation (Rule 4); and because the therapeutic claims are unwarranted (Rule 6).—(From Reports of Council on Pharmacy and Chemistry, 1919, p. 65)

ARHOVIN OMITTED FROM N. N. R.

Report of the Council on Pharmacy and Chemistry

Arhovin is a solution of dephenylamine, thymol benzoate and ethyl benzoate, marketed by Schering and Glatz, Inc. It was omitted from New and Non­official Remedies because the therapeutic claims made for the preparation were unwarranted and because the firm had refused to discontinue the distribution of the advertising which contained the objectionable claims prior to Jan. 1, 1919. When the report which appears below explaining the dismissal was submitted to Schering and Glatz, Inc., the firm again promised a revision of its advertising, but refused discontinuance of the objectionable circular before Jan. 1, 1920. Since Arhovin is still marketed with unwarranted therapeutic claims, the Council has authorized publication of this report.

W. A. Puckner, Secretary.

The attention of the firm Schering and Glatz, Inc., was called to misleading statements in its booklet for Arhovin in 1915, and in 1918 the firm was informed that unless the misleading statements were withdrawn before Jan. 1, 1919, Arhovin would be omitted from New and Non­official Remedies.

The following quotations are taken from the circular in question, and illustrate the character of the claims to which objection was made:

“Striking also is the antiphlogistic and anesthetic effect of Arhovin on the inflamed mucosae, an effect which, as all authorities agree, is far greater than that of all other internal anti-gonorrheaics.”

“Under its influence vesical and prostatic complications, gonorrheal arthritis, endocarditis, etc., are rarely incurred.”

References to the indexes of leading textbooks, including those of Meyer and Gottlieb, Cushny, Sollman and Bastedo, fails to show that Arhovin is so much as mentioned by those authors; hence, it is obviously false to state, as is done in the first of the quotations above, that all authors agree concerning the striking effects of Arhovin.

Many of the statements are objectionable by reason of the actions implied, rather than stated directly. The following are examples:

“Arhovin in Gonorrheal Infections of the Male Genito-Urinary Organs. Anterior Urethritis. This is the class of cases in which the most favorable results from Arhovin have been reported.”

“Posterior Urethritis.

“Here also the striking effects from Arhovin medication, both in acute and chronic cases, are rapid decrease of discharge, disappearance of gonococci from the secretion, and cessation of subjective difficulties, such as strangury.”

While the firm did not agree to withdraw the objectionable advertising before Jan. 1, 1919, which made necessary the omission of Arhovin from New and Non­official Remedies, 1919, it did submit a proposed folder in which the most objectionable of the claims are still made.

The following statement, which was in the proposed “folder” and is included in an advertising pamphlet sent out during 1919, serves to illustrate those points:

“Its action is three-fold:

“Strong antiseptic and bactericidal effect upon the urethral and vesical mucosae, highly conducive to shortening and palliation of the acute disease course.”

No evidence has been presented that Arhovin is capable of destroying the gono­coccus in the urethra, and consequently, the Council declared the recommendation for the use of Arhovin in the treatment of gonorrhea, by means of claims such as those just cited, is both misleading and dangerous.—(From Reports of Council on Pharmacy and Chemistry, 1919, p. 66)

CHLORON, CHLORAX AND NUMBER “3”

Report of the Council on Pharmacy and Chemistry

The report which appears below was sent to the Chlorine Products Company, Inc., May 14, 1919. In reply to an inquiry sent the Chlorine Products Company, July 8, the company wrote that it could send no reply because the medical director was still in France. However, Chloron and Chlorax are being advertised in medical journals; also essentially the same advertising as that discussed in the report was recently received by a physician from the Chlorine Products Company.

The preceding facts having been reported to the Council, publication of the report was authorized.

W. A. Puckner, Secretary.

Chloron, Chlorax and Number “3” are preparations of essentially similar composition put out by the Chlorine Products Company, Inc., New York.

Chloron

Chloron, according to the label, is “A stable CHLORINE remedy for the reduction of inflammation, relief of pain and for all wounds, burns, scalds and every description of sores except cancer and lupus.” Its composition is given as:

“Free chlorine, 0.200 per cent.; calcium chloride, 0.190 per cent.; mercurous chloride, 0.030 per cent.; lithium chloride, 0.035 per cent.; calcium hydrate, 0.010 per cent.; water to 100 parts.”

The Council asked the manufacturers for further information in regard to the composition or preparation of Chloron and received this reply:

“Chlorine gas is prepared in the usual way and purified and passed into water until a saturated solution is made.

“Water to the extent of three times the volume of the chlorine solution is used to dissolve the necessary amount of calcium chloride, and the two solutions are mixed.

“The necessary amounts of Lithium and Mercurous Chloride are then intimately mixed and made into solution. This solution is then added to the above and the whole is agitated for some minutes.”

A specimen of Chloron was examined in the A. M. A. Chemical laboratory and the chemists reported:

Qualitatively the presence of the following constituents was confirmed: calcium, mercury, lithium, chlorid, free chlorin. The solution was alkaline. Of course, the declaration that Chloron contains mercurous chlorid (calomel) is obviously incorrect, as mercurous chlorid cannot exist in a solution containing active (free) chlorin, but is oxidized to mercuric chlorid (corrosive sublimate). As the solution was alkaline in reaction, it seemed unlikely that all the active chlorin was present in the free state, as declared on the label. Quantitative determination of free chlorin and of total active (“available”) chlorin gave: free chlorin, 0.036 gm. per hundred c.c.; total “available” chlorin, 0.330 gm. per hundred c.c., or 165 per cent. of the claimed amount.

A comparison of the information sent to the Council with the analytic findings leads to the conclusion that Chloron is not of reliable composition.

As evidence of the therapeutic value of Chloron, the following “case reports” were submitted:

“In a case of second degree burn involving the most of one leg from the middle of the calf down, Chloron was the only dressing used. The burn was a bad one and the patient in a rundown anaemic condition, at no time was there any appearance of pus, the surface looked clean and bright and the healing was accomplished with practically no scar whatever. The burn was kept wet with the solution by hourly applications day and night. The skin which has grown on the wound is clear, healthy and firm.

In another case of Varicose veins of long standing, the result was surprising. The patient told of two years vibrating from Hospital to Hospital and getting no real relief. Each leg had large open running sores, the only dressing used was wet compresses of this solution. The pus disappeared at once, the wound began to cicatrise from the edges and in two weeks the man was discharged from the hospital practically cured.”

“Chloron was recently tried at the —— and —— Hospital on cases presenting ulcers and other sores which did not readily yield to other methods, with good results, in fact were of an indolent type. In these cases Chloron proved very valuable.”

“I have used Chloron on a series of cases (surgical) presenting pus foci and I have found the application very beneficial and healing, the pus early disappearing. In cases of Osteomyelitis, Suppurating Arthritis, Cellulitis and Chronic Ulcers, Chloron is particularly valuable, its good effects quickly observed and the time of restoration to health shortened.”

In the first case report, there is no evidence that Chloron is more efficient in the treatment of burns than any other commonly used procedure might have been. In the case of the varicose ulcers, while there was some apparent benefit from Chloron, no credit is given to rest and the general treatment which is known to be important in the treatment of such conditions. The evidence in the other case reports is quite inconclusive. Consideration of the “case reports” leads to the conclusion that clinical evidence for the value of Chloron is lacking.

Attention should be called to the fact that the amount of active chlorin, claimed to be present in Chloron as well as the amount found by the association laboratory, is less than that considered effective by Dakin, Dunham and others; seemingly in preparing Chloron no attention has been paid to the degree of alkalinity, yet the importance of this factor is now generally recognized.

Chloron fails to comply with the requirements for surgical solution of chlorinated soda (N. N. R., 1919, p. 133), yet the manufacturers make free use of the text of Dakin and Dunham’s Handbook of Antiseptics in their advertising pamphlet. Thus:

From the Chloron pamphlet:

“This ideal antiseptic effects com­plete ster­il­iza­tion within its sphere of action with­out caus­ing any dam­age to the cells or tis­sues. An im­por­tant method of judg­ing the in­juri­ous action of anti­sep­tics is to in­ves­ti­gate their ef­fects on the leuco­cytes. From ex­peri­ments in vitro by Parry Morgan and in vivo by Col. C. J. Bond with the strength of anti­sep­tics com­mon­ly used in sur­gery, it has been found that Chlorine anti­sep­tics and mer­cury salts have lit­tle ef­fect on phago­cyt­osis in com­pari­son with other germi­cides.

The ac­tivi­ty of the leuco­cytes from wounds which have re­cent­ly been treat­ed with CHLORON may be de­mon­strat­ed ex­peri­ment­ally.”

“In add­ition to its anti­sep­tic action CHLORON is a strong oxi­diz­ing agent and de­odor­ant and pos­ses­ses to a marked de­gree the prop­erty of de­com­pos­ing tox­ins. In this con­nec­tion it is in­ter­est­ing and per­tin­ent to note that Dean, by the regu­lat­ed action of hypo­chlor­ous acid, has pre­pared a non­toxic dys­en­tery vac­cine and it is now a com­mon ob­ser­va­tion that the free use of CHLORON may re­duce the con­sti­tu­tion­al symp­toms aris­ing from sep­tic pro­ces­ses and that they re­ap­pear on dis­con­tinu­ing the anti­sep­tic treat­ment.”

Dakin and Dunham Handbook of Antiseptics:

“The ideal surgical anti­sep­tic should ef­fect com­plete ster­il­iza­tion within its sphere of ac­tion with­out caus­ing any dam­age to ani­mal cells. At the mo­ment such a sub­stance does not ap­pear likely to be found, but on the other hand it is sur­pris­ing to see how lit­tle dam­age may be done to ani­mal tis­sues by some ac­tive anti­sep­tics. An im­por­tant me­thod of judg­ing of the in­juri­ous ac­tion of anti­sep­tics is to in­ves­ti­gate the con­di­tion of the leuco­cytes in wounds re­cent­ly treat­ed with the sub­stance under con­si­der­ation. In gener­al it appears from ex­peri­ments in vitro that, with the strength of anti­sep­tics com­mon­ly used in sur­gery, mer­cury salts and hypo­chlor­ites have rela­tive­ly lit­tle ef­fect on phago­cyt­osis as com­pared with phe­nol (Parry Morgan). It is a regu­lar phe­nom­enon to ob­serve ac­tivi­ty of the leuco­cytes ob­tained from wounds which have been re­cent­ly treat­ed with hypo­chlor­ites.

Ingenious methods for determin­ing the in­flu­ence in vivo of anti­sep­tics on the ac­tivi­ties of leuco­cytes have been worked out by Col. C. J. Bond.

“In addition to their dis­in­fect­ing ac­tion, the Chlorine anti­sep­tics are strong oxi­diz­ing agents and de­odor­ants and more­over pos­sess in high de­gree the pro­perty of de­com­pos­ing toxins. By the re­gu­lat­ed ac­tion of hypo­chlor­ous acid, Dean has pre­pared a non­toxic dys­entery vac­cine and it is a com­mon ob­ser­va­tion that the free use of hypo­chlor­ites may re­duce the con­sti­tu­tion­al symp­toms aris­ing from sep­tic pro­ces­ses and that they re­ap­pear on dis­con­tinu­ing the anti­sep­tic treat­ment.”

Chlorax

Chlorax is said to be “A stable CHLORINE solution for internal use,” in “Kidney Conditions,” “Diabetes,” “Acute Infections,” “Blood Dicrasias,” “Lithemias and Rheumatism,” and “Nervous Conditions.” It is claimed to have the same composition as that of Chloron with the addition of 0.016 per cent. of tincture of opium.

The A. M. A. Chemical Laboratory reported that the free chlorin in Chlorax was 0.01 gm. per hundred c.c. and the total amount of active (“available”) chlorin was 0.25 gm. per hundred c.c., or 125 per cent. of the amount claimed. The laboratory notes that though the chlorin content of Chloron and Chlorax is claimed to be the same, that of Chlorax actually is less. This is not surprising when the presence in Chlorax of reducing substances such as alcohol is borne in mind. The laboratory concludes that Chlorax is not of reliable composition.

The following is typical of the “case reports” submitted to show the value of Chlorax:

“In January last I used Chlorax on a case of Diabetes Mellitus and with excellent results.

“The patient had been suffering for about nine years and when first brought to my care Toxemia had set in, he was drowsy, irritable and unable to leave the house. I prescribed Chlorax in teaspoonful doses four times a day and am pleased to say that in one week he showed marked improvement. Soon after he was able to leave the house and attend to his business and after two months’ treatment resumed a normal diet and habits apparently without injurious effects.

“I believe that in this case Chlorax undoubtedly prolonged life.”

No mention is made of the dietary or other measures used. The wide variation in diabetes and its response to proper diet is so well known that the noncommittal statement concerning the beneficial effects of Chlorax amounts to no evidence at all in favor of the preparation.

The other “case reports” furnished by the Chlorine Products Company, Inc., which concern the treatment of gastric ulcers, acute alcoholic gastritis, tonsillitis, etc., are equally unconvincing. In fact, no satisfactory evidence for the clinical value of Chlorax has been presented.

The following from the advertising for Chlorax is unwarranted and absurd:

“Mercurous chloride (calomel) is perhaps the most widely used internal antiseptic and alterative and has established itself in the therapy of constipation, cholera, dysentery, cardiac dropsy, pleurisy, malignant fever, malaria, syphilis, worms, infectious diseases, gout and rheumatism; lithium chloride is particularly efficacious in acute and chronic parenchymatous nephritis and in various lithemic conditions; while Opium has no rival as an anodyne and can be used to stabilize and conserve the alkaline reserve of the body against the acidosing influence of infections.”

Further, on page 14 we find:

“In chills and fever malaria and other blood dicrasias, Chlorax is indicated as an internal antiseptic and it exerts a beneficial effect on the course of these diseases.”

The claims made for Chlorax are exaggerated and misleading.

Number “3”

According to the label, Number “3” is “A STABLE CHLORINE remedy for the purification of the blood,” with the composition:

“Free Chlorine, 0.35 per cent.; Calcium Chloride, 0.30 per cent.; Mercurous Chloride, 0.03 per cent.; Lithium Chloride, 0.04 per cent.; Calcium Hydrate, 0.01 per cent.; Opium, 0.02 per cent.; Ethyl Alcohol, 0.10 per cent.; water to 100 parts.”

It will be noticed that the composition claimed for Number “3” is essentially similar to that claimed for Chloron. It differs from Chloron in that the amounts of some of the constituents are somewhat greater, and in that, like Chlorax, it contains some tincture of opium.

The A. M. A. Chemical Laboratory reports that the free chlorin in a specimen of Number “3” was 0.024 gm. in 100 c.c. and the total active (“available”) chlorin 0.173 gm. per hundred c.c., or about 50 per cent. of the claimed amount. The examination indicates that Number “3” is of unreliable composition. The Chlorine Products Company, Inc., submitted no clinical evidence for Number “3” to which it refers as “our Syphilis remedy.” It stated that two physicians had used the preparation “with good results,” and admitted that “the company requires further evidence before pushing it.”

The Council declared “Chloron,” “Chlorax” and “Number ‘3’ ” in conflict with the rules governing admission to New and Non­official Remedies. All are of unreliable composition (conflict with Rule 1). The therapeutic claims made for the preparations are not substantiated by acceptable evidence and are unwarranted and misleading. Chloron is inferior as an antiseptic to the well-known surgical solution of chlorinated soda on account of its low chlorin content and uncontrolled reaction. There is no warrant for the claim that Chlorax is useful in the treatment of “Kidney Conditions,” “Diabetes,” “Acute Infections,” “Blood Dicrasias,” “Lithemias and Rheumatism,” and “Nervous Conditions,” nor is there warrant for the claim that “Number ‘3’ ” is a remedy for the purification of the blood or a “Syphilis remedy” (conflict with Rule 6).

The names of these pharmaceutical mixtures are not descriptive of their composition (conflict with Rule 8).

All three preparations are irrational. No evidence has been furnished that the lithium salt is of value in the mixtures. It is not rational to combine an active chlorin preparation and a mercury salt in one mixture, nor is there evidence that the addition of opium to the preparations proposed for internal use is of value or rational. Experimentation with Number “3” as a “Syphilis remedy” is to be severely condemned in that those on whom it is used will in the meantime be deprived of efficient medication (conflict with Rule 10).—(From Reports of Council on Pharmacy and Chemistry, 1919, p. 70)

ELARSON OMITTED FROM N. N. R.

Report of the Council on Pharmacy and Chemistry

The Council has authorized publication of the following report announcing the omission of Elarson from New and Non­official Remedies.

W. A. Puckner, Secretary.

Elarson, now sold by the Winthrop Chemical Company, Inc., was formerly sold in the United States by the Bayer Co., Inc. It was admitted to New and Non­official Remedies in 1914.

The circular issued by the Winthrop Chemical Co. contains several statements markedly at variance with the results of an investigation made, at the request of Fischer, by Joachimoglu (Arch. f. exper. Path. u. Pharmakol. 78:1914). The circular states that Elarson contains about 13 per cent. arsenic. Joachimoglu found from 10.8 to 11.1 per cent. to be present. The circular states further:

“The fact that Elarson represents a lipoid-like chemical combination of arsenic has an important bearing upon its absorption and utilization in the system ... there is good reason to believe that when arsenic is administered in a stable, lipoid-like combination, as in Elarson, it is more readily taken up by the cells and more completely utilized than when given in the customary manner.”

“As regards the behavior of Elarson in the system, it has been shown that its active constituent, chlorarseno-behenol, is almost completely absorbed in this form, probably as a chlor-behenolate of sodium or potassium.”

As a matter of fact, Joachimoglu found that very little arsenic was absorbed when Elarson was given to dogs and rabbits; most of it was recovered from the feces; only traces were found in the liver and kidneys and none in the blood and brain. The absence from the latter organs shows that the lipoid solubility does not obtain in the body. It is claimed in the circular that Elarson has the advantage over Fowler’s solution “in that it is free from any irritating action upon the gastro-intestinal tract”; it is stated that as many as sixty tablets have been given to dogs daily without any toxic effects. Joachimoglu, on the other hand, found powdered Elarson to be very irritating to the gastro-intestinal tract; also that the dog could not stand sixty tablets at all (gar nicht vertragen), such doses causing vomiting, diarrhea and intestinal hemorrhages; on repeated administration the symptoms became progressively more severe. Joachimoglu also found that, compared on the basis of arsenic content, Elarson, given intravenously, is from ten to twelve times as poisonous as arsenic trioxid. Elarson is recommended for the class of cases in which Fowler’s solution is used.

To sum up: None of the special claims made for Elarson—the arsenic content, ready absorbability, freedom from irritating action on the gastro-intestinal tract and its alleged better adaptation for continued administration—have been substantiated; on the contrary, they have been disproved as well as the theory of its mode of absorption proposed by Fischer and Klemperer. Furthermore, Joachimoglu found that when it actually got into the circulation (intravenous injection) in the form in which Fischer and Klemperer supposed it to be absorbed, it was from ten to twelve times as toxic as arsenic trioxid.

The Council voted to omit Elarson from New and Non­official Remedies because it is sold under unproved and consequently unwarranted claims and because it is an unscientific and relatively useless article. Elarson has not been shown to have advantages over Fowler’s solution; on the contrary, in some respects at least, it is inferior.—(From Reports of Council on Pharmacy and Chemistry, 1919, p. 75.)

IODIPHOS

Report of the Council on Pharmacy and Chemistry

A report which appears below was sent Charles L. Heffner for consideration. No reply having been received, the Council authorized its publication.

W. A. Puckner, Secretary.

Iodiphos, marketed by Charles L. Heffner, Brooklyn, N. Y., is declared to contain ferric citro-iodine, 6 grains; calcium glycero­phosphate, 8 grains; sodium glycero­phosphate, 8 grains, and hypophosphorous acid, 2 minims in each fluidounce, and to present “the Metallic and Non-Metallic elements: Iron, Iodine, Phosphorous, Calcium and Sodium (each in separate Basic combination).”

According to the label, Iodiphos is “Alterative, Tonic, Nervine and Anti-tubercular” and is “For Treatment of BLOOD, NERVES and PULMONARY ORGANS.” An advertising circular129 asserts that “Iodiphos exerts its Physiological action rapidly in hardening of the Arteries, High Blood Pressure, Anaemia, Glandular Swelling, Neurasthenia, Hypochondria, Phthisis, Bronchitis, Asthma, Pneumonia and as an Intestinal Antiseptic and Appetizer,” and declares it to be “Indispensable as a Tonic and Restorative.”

In the advertising circular it is averred that in the production of Iodiphos “Chemistry Again Aids the Modern Physician.” Iodiphos is another instance when a decadent polypharmacy proposes haphazard medication and so obstructs the efforts of modern medicine to establish the use of single drugs to meet definite indications.

Iodiphos is inadmissible to New and Non­official Remedies because it is an irrational mixture of drugs sold with therapeutic claims that are unwarranted, and under a name which is not descriptive of its composition.—(From Reports of Council on Pharmacy and Chemistry, 1919, p. 81.)

MERVENOL AND ARMERVENOL NOT ADMITTED TO N. N. R.

Report of the Council on Pharmacy and Chemistry

The Council has authorized publication of the report which appears below declaring Mervenol and Armervenol, marketed by the Hille Laboratories, inadmissible to New and Non­official Remedies.

W. A. Puckner, Secretary.

Mervenol is stated by the proprietors—The Hille Laboratories, Chicago—to be a hydrosol (colloidal suspension) of the sulphides of mercury and copper, containing sufficient sodium chloride to make it isotonic with blood serum, and “inert proteid” and “carbohydrate” to stabilize the colloidal suspension: each cubic centimeter is stated to contain 0.005 gm. mercury, 0.0016 gm. copper, and 0.0016 gm. sulphur.

It is claimed that this preparation is of value in pneumonia, influenza, and other conditions and diseases requiring increased leukocytosis.

It is further claimed that the properties and therapeutic effects of this preparation are as follows: “Practically non-irritant; practically non-toxic; lower temperature, often crisis like; lower pulse, with better elimination; greatly accelerated recovery from Influenza; fewer Pneumonia complications; lower mortality rate in Influenza and Pneumonia; remarkable Leucocyte stimulation.” Administration by mouth and by intramuscular and intravenous injection are advocated.

In the recent influenza epidemic, it is reported that therapeutic results of some value were obtained at the Great Lakes Training Station and at Fort Sheridan. The reports of certain medical officers indicate that this preparation seemed to have some effect on the course of pneumonia and influenza, on the temperature, and on the leukocyte count. But those conducting the experiments state that it was “absolutely impossible” to fulfil ideal conditions as to controls and other observations at the time the experiments were conducted.

So far as the Council knows, no effort has been made to determine the potent constituent, or constituents, of this preparation; whether the mercury, the copper, or the protein in the mixture was responsible for the claimed benefits is an open question.

These reports were given careful consideration, but it was decided not to accept this preparation because of (1) exaggerated therapeutic claims, conflicting with Rule 6 (aside from the report of its use in influenza and pneumonia at the Great Lakes Training Station and the Post Hospital at Fort Sheridan, which reports are of work done and observations made under conditions which did not permit careful controls, no evidence has been presented to the Council supporting the therapeutic claims) and (2) being an irrational mixture, conflicting with Rule 10—a mixture containing colloidal mercury, copper and sulphur with proteins and carbohydrates in addition, it is difficult to predict the changes which occur in such mixtures on standing.

Samples of Mervenol (two 1-ounce bottles) submitted by the manufacturer, June 5, 1919, were found when opened, Aug. 18, 1919, to have undergone decomposition. A very disagreeable odor had developed, the liquid was turbid, and a large amount of precipitate had formed.

Armervenol is stated by the proprietors—The Hille Laboratories, Chicago—to be a hydrosol (colloidal suspension) of “mercury-copper-sulpharsenite” containing sufficient sodium chlorid to make it isotonic with blood serum and “inert proteid” and “carbohydrate” to stabilize the solution: each cubic centimeter is declared to contain 0.0025 gm. arsenic, 0.005 gm. mercury, 0.0016 gm. copper, and 0.0032 gm. sulphur.

The use of Armervenol as advised by the Hille Laboratories is the same as that of Mervenol, and in addition its use in syphilis is emphasized. The criticisms of this mixture are similar in every respect to those directed against Mervenol—the addition of arsenic introduces still another factor of uncertainty.

After investigating these claims, it was decided not to accept this preparation on the ground (1) that the therapeutic claims are unproved and unwarranted, conflicting with Rule 6, and (2) that the mixture is an irrational one, conflicting with Rule 10.—(From Reports of Council on Pharmacy and Chemistry, 1919, p. 82.)

NORMAL PHENOL SERUM (CANO) AND METHYL-PHENOL SERUM (CANO) NOT ACCEPTED FOR N. N. R.

Report of the Council on Pharmacy and Chemistry

The Council has adopted the following statement declaring Normal Phenol Serum (Cano) and Methyl-Phenol Serum (Cano) ineligible to New and Non­official Remedies.

W. A. Puckner, Secretary.

No statement of the composition of these preparations was submitted to the Council and none appears on the labels of the trade packages. However, the advertising circular contains statements such as:

“... normal phenol serum—phenol with methyl blue dissolved in anaphylactic serum ...”

“... a combination of human or horse serum with Phenol and Methylene-blue, thereby forming a new chemico-biologic product which he termed Methyl-phenol Serum or, chemically, Chloride of Phenol Thionin Tetra­methylene-Seric.”

“Methyl-phenol Serum is a chemico-biological product in which Phenol is the chief factor. Each ampule of 10 c.c. contains the therapeutic equivalent of 0.5 gm. (7.5 grains) of Phenol.”

From the foregoing it appears that both preparations contain phenol and methyl­thionine chloride (methylene blue) and that the second does not contain methyl phenol (cresol) as the name would indicate.

No definite evidence for the value of these preparations is brought forward and even the manufacturer is constrained to caution, “We assume no responsibility for the therapeutic action of the serum....” On the other hand there are a great many statements in the papers of Cano and his colleagues to which exception must be taken. Of these, from among many similar, the following statements are to be cited and commented on:

“Accepting that the gonorrheal infection gives systemic toxemia from absorption of the toxins ...”

It is the general opinion that in the majority of instances there is no systemic toxemia.

“The technique of intraprostatic injection, while less simple than that of the intravenous, is by no means so difficult or complicated as to place it exclusively in the category of the urologist.”

This obviously is an attempt to encourage the general use of these preparations and to minimize the necessity for careful study and special skill in their employment. It is most unwise for one to attempt intraprostatic injections unless he is specially trained in the technique of this procedure.

“This injection to be performed after the 5th or 6th intravenous injection of Methyl-phenol Serum....”

Intravenous injections have a place in sane therapy only when the medicament to be so administered is of known composition and when evidence is available which gives assurance that definite results shall follow its use. In the absence of these conditions it is manifestly unwise and even unexcusable to employ any medicament in this manner, and its repeated use is reprehensible.

“Intravenous injection of Methyl-phenol Serum alternating with intravenous injections of mercury should be given every 48 hours until infection is under control.”

This quotation further emphasizes that the treatment, as advised, carries with it a certain element of danger.

“Methylene blue prevents the phenol from exerting its usual action upon the red blood corpuscles, and ensures rapid elimination through healthy kidneys. It preserves the antiseptic power of the phenol and prevents the phenol from interfering with the chemico-biological function of the white and red blood cells. The serum component favors chemotaxis, it strengthens bodily defense, it prevents anaphylaxis even in debilitated patients, and it replaces the resistance which has been impaired by the demands that have already been made upon it.”

No evidence is submitted to substantiate these claims. It seems strange that phenol should lose its power and that this should be restored by the methylene blue.

“It has a refractory chemico-biological action, and exercises no vicious effect on the red blood corpuscles in the circulation, but, on the contrary, by its inoffensive presence, it wholly preserves all of the physiological properties of the blood.”

What “a refractory chemico-biologic action” is, is not clear, but there is no evidence that this preparation has any action which might be defined as “refractory chemico-biological,” that its presence is inoffensive or that it wholly preserves all the physiologic properties of the blood.

“The treatment of gonorrhea by Cano’s theory ... is firmly based upon chemico-biological facts and accepted authoritative theories and bears the same relation to gonorrhea that intravenous injections of arsenicals bear to syphilis.”

Quite an exaggerated and unwarranted statement. In the same way, objection is taken to the following quotations:

“Phenol administered intravenously in combination with methylene blue, to protect the red-blood globule, undergoes no change, and preserves all of its actual antiseptic effect on the gono­coccus and its toxins as though employed in the test tube.”

“When thus introduced into the human body its elimination is unique, effective, antiseptic, germicidal, being completely and exclusively thrown off through the kidneys in a period varying from one-half to twelve hours without local injury or disturbance to the general economy.”

“Combinations of phenol are unstable, but they do have the advantage of mitigating direct action on the cells and globules. It is also known that ordinary phenol has a coagulant action on the albumins and an oxidizing power on the tissues, which power, if permanent, produces gangrene. By virtue of this dual action it therefore acts as a modifier; by its oxidizing power on the germ it is germicidal, and prevents the growth of the gono­coccus; and by its coagulant power on the toxins it relieves para­gono­coccal lesions (mono- and poly-arthritides) and affections of the serous organs (endo- and pericarditis, meningitis), and some definite systemic disturbances, the pathology of which is often confused with that of other infections.”

“Lymphocytosis is often persistent in some individuals in whom the internal secretions and the processes of assimilation and disassimilation are deficient; and because of the lack of these the organic physiological ferments are insufficient for the mechanism of nutrition and the phenomena of hematopoiesis.”

Until proof is available showing that phenol, administered intravenously in the quantities employed in Cano’s Normal Phenol Serum and Cano’s Methyl-Phenol Serum, acts as a germicide and methyl­thionine chloride (“methylene blue”) prevents the deleterious effects of phenol on the red blood corpuscles; that repeated intravenous injections of phenol and mercury are without danger; that there is no danger of anaphylaxis; that the physiologic properties of the blood are preserved by these medicaments; and, finally, that these preparations have an effect on gonorrhea and its complications, these substances Normal Phenol Serum (Cano) and Methyl-Phenol (Cano), are inadmissible to New and Non­official Remedies.

The following quotations taken from the circular are admissions that these preparations are not innocuous:

“That the economy will tolerate to a surprising degree substances directly introduced through the blood stream is now well known. By the intravenous injection of 10 c.c. of methyl-phenol serum we throw into the human body a massive dose of an alien substance. The immediate effect of this injection is upon the central nervous system. The recipient usually becomes either pale or suffused, he has a ringing in his ears, has a sensation of great altitude, and occasionally has a dryness of the fauces and a metallic or a garlic taste.”

“In some patients secondary reactions occur in from one to four hours after injection. The phenomena we have observed in these secondary reactions are pronounced chill and rigor ...”

There is no doubt that considerable harm may be done by the intravenous and by the intraprostatic administration of these preparations and until there is good evidence showing the therapeutic value of the treatment, the routine use of these preparations, except perhaps at hospitals in selected and well controlled and carefully guarded cases, is to be strongly discouraged.

When the foregoing statement was sent to the Mulford Company for comment, the firm submitted a letter from Dr. Perry Townsend to the Mulford Company in which he declared that the results obtained with the Cano preparations had been satisfactory and without untoward results. In this letter, Dr. Townsend proposed that a series of injections with these preparations be carried out under the observation of members of the Council and the supervision of Dr. Cano or himself.

The report of the Council, the letter from the Mulford Company and that of Dr. Townsend were sent to a number of urologists for their opinion concerning this whole matter. It was explained that the referee held that no reason had been presented which would warrant the Council to depart from its customary procedure, namely, to require that clinical evidence be submitted in the form of published reports which permit investigation and verification by independent observers but that, before making further recommendation to the Council, he desired the opinion of urologists of recognized standing concerning the report submitted to the Mulford Company. All replies received approved the Council’s position.

The following is one of the replies received:

Your letter in regard to Normal Phenol Serum (Cano) and Methyl-Phenol Serum (Cano) received. I wish to state that I have read the correspondence between the Council and H. K. Mulford Co. and in my opinion the referee and the Council are quite correct in their attitude in the matter. In my opinion I would emphasize the following:

(1) There is absolutely nothing about the remedies directed specifically against the gono­coccus and no evidence to show that any action against them is obtained. As we know there are certain states of normal serum which are highly toxic and any normal serum from another animal will produce disturbances in man when injected intravenously—particularly if repeated. The addition of substances to serum normal or otherwise is apt to and frequently does render that serum highly toxic! The substances added in the instances referred to—phenol and methylene blue are not in any way calculated to lessen the toxicity of serum. The element of danger existing in the indiscriminate use of serums intravenously is, in my opinion, increased by the addition of the substances mentioned, and it would be unwise to encourage the general use of any such remedies. Furthermore the products are condemned by the very evidence of the originators and their admissions are quite sufficient to deter anyone from using the products as they suggest.

As to the intraprostatic injections with the serums it does not at all meet my views; although the introduction of serums by this route have been frequently advocated and I have personally carried this mode out I cannot allow the impression to go out that it could be done in a routine manner—nor that no ill results could follow—for I have seen otherwise. Furthermore from theoretical standpoint serums need not be given in this way.

In consideration of the opinion expressed by the Council’s consultants the referee recommended that Normal Phenol Serum (Cano) and Methyl-Phenol Serum (Cano) be declared ineligible for New and Non­official Remedies because of conflict with Rule 6 (unwarranted therapeutic claims) without considering possible conflicts with other rules, and that publication of the report be authorized.—(From Reports of Council on Pharmacy and Chemistry, 1919, p. 85.)

SOAMIN OMITTED FROM N. N. R.

Report of the Council on Pharmacy and Chemistry

Soamin is the name under which the firm of Burroughs Wellcome and Company sells its brand of sodium arsanilate. The Council directed the omission of Soamin from New and Non­official Remedies and authorized publication of the report which appears below after the proprietors of the product had declined to withdraw or suitably revise the unwarranted therapeutic claims which it made.

W. A. Puckner, Secretary.

The proprietary brand “Soamin” of sodium arsanilate was admitted to New and Non­official Remedies several years ago at a time when the therapeutic value of arsanilic acid had not been definitely determined. Experience with this drug has shown that it is far more dangerous and also has a more limited field of usefulness than was at first recognized. The proprietors of the Soamin brand have continued to include in the list of conditions in which it “would seem” to be a “very effective agent” cerebrospinal meningitis and pellagra; in fact, meningitis is the first in the list of conditions mentioned, syphilis the second and pellagra third. In support of their belief in the efficacy of the remedy in meningitis, three reports, published from six to nine years ago, are quoted. In one of these it is stated that two patients “were cured”; in another report, seven of eight patients in whom the clinical, but not the microscopic, diagnosis of meningitis had been made were reported as having recovered; in the third report, fifty-six of ninety cases were reported cured; in this larger series of cases the author neglects to state the method of administration. The firm quotes but one paper (which is a very uncritical report) in regard to pellagra.

It seems to the Council that the evidence of value of sodium arsanilate in these conditions (which are now treated by more rational methods) is too slight to justify the emphasis laid on it by the firm, especially as sodium arsanilate is admittedly a dangerous agent, several cases of blindness having been reported from its use.

For these reasons it was voted to omit Soamin from New and Non­official Remedies.—(From Reports of Council on Pharmacy and Chemistry, 1919, p. 89.)

SOME MIXED VACCINES NOT ADMITTED TO N. N. R.

Report of the Council on Pharmacy and Chemistry

The Council has authorized publication of the following report.

W. A. Puckner, Secretary.

The consideration of the following “mixed” vaccines was requested by F. I. Lackenbach, San Francisco:

Special Bacterial Vaccine No. 2 (Staph-Strep. Bacterin) containing killed Staphylo­coccus albus, Staphylo­coccus aureus and strepto­coccus.

Special Bacterial Vaccine No. 3 (Pneumo-Staph-Strep. Bacterin) containing killed Staphylo­coccus albus, Staphylo­coccus aureus, strepto­coccus and pneumo­coccus.

Special Bacterial Vaccine No. 4 (Pneumo-Staph-Strep-Coli Bacterin) containing killed Staphylo­coccus albus, Staphylo­coccus aureus, Staphylo­coccus citreus, Bacillus coli, strepto­coccus and pneumo­coccus.

Special Bacterial Vaccine No. 5 (Influenza Combined Bacterin) containing killed Staphylo­coccus albus, Staphylo­coccus aureus, Bacillus Friedländer, Bacillus influenzae, Micro­coccus catarrhalis, strepto­coccus and pneumo­coccus.

Special Bacterial Vaccine No. 11 (Pneumo-Strep. Bacterin) containing killed strepto­coccus and pneumo­coccus.

Special Bacterial Vaccine No. 15 (Combined Whooping Cough Bacterin) containing killed Bacillus pertussis, Staphylo­coccus albus, Staphylo­coccus aureus, Micro­coccus catarrhalis, Bacillus influenzae, strepto­coccus and pneumo­coccus.

Special Bacterial Vaccine No. 16 (Mixed Gono­coccus Bacterin) containing killed gono­coccus, Staphylo­coccus albus, Staphylo­coccus aureus, Bacillus coli, diphtheroid bacillus, strepto­coccus and pneumo­coccus.

Mr. Lackenbach states that these bacterial mixtures were prepared for him by E. R. Squibb & Sons. Their sale in interstate commerce is permitted under the license granted to the latter firm by the U. S. Treasury Department. However, no evidence of any kind was presented to the Council proving the therapeutic efficacy of the several mixed vaccines. As a mixture of two or more kinds of organisms is accepted for New and Non­official Remedies only if there is satisfactory evidence that its therapeutic use is rational, the Council declared the several vaccine mixtures ineligible for New and Non­official Remedies (Rule 10).—(From Reports of Council on Pharmacy and Chemistry, 1919, p. 90.)

SOMNOFORM

Report of the Council on Pharmacy and Chemistry

The Council examined the available evidence for Somnoform, sold by Stratford-Cookson Company, successors to E. de Trey and Sons, and found the preparation inadmissible to New and Non­official Remedies. The Council authorized publication of the report which appears below.

W. A. Puckner, Secretary.

Somnoform is sold in the United States by Stratford-Cookson Company, successors to E. de Trey and Sons. According to the label on a package of Somnoform sent the Council.

“This mixture contains Chloride of Ethyl, 83 per cent.; Chloride of Methyl, 16 per cent.; Bromide of Ethyl, 1 per cent.”

Although Somnoform has been on the market for a long time, the published reports present no proof that it is superior to ethyl chlorid used alone. Moreover, the published reports and statistics do not necessarily apply to the Somnoform now sold for the reason that mixtures of varying composition have been sold as Somnoform in the past. Thus, when Somnoform was considered by the Council in 1909, it was claimed to be composed of chloride of ethyl, 60 per cent.; chloride of methyl, 35 per cent., and bromide of ethyl, 5 per cent. Federal chemists found, however, that it contained no bromide of ethyl (Notice of Judgment No. 571). It is a question, therefore, whether a given report applies to a mixture containing 5 per cent. bromide of ethyl, 1 per cent. of this substance, or none at all.

The present advertising booklet for Somnoform does not present acceptable evidence of the therapeutic value of the preparation. An ignorance concerning the elementary facts of physiology and pharmacology is evident in the second sentence: when having stated that “Somnoform is the result of several years of study and investigation by Dr. George Rolland, Dean of the Bordeau Dental School,” the pamphlet continues: “He sought an anesthetic which would enter, dwell in, and leave the body in the same manner that oxygen does....”

The claim as to the value of the 1 per cent. of ethyl bromide in the mixture is highly improbable; certainly no evidence in support of the claimed value of this constituent is available to the referee.

No evidence is submitted which proves the claim of superiority of Somnoform over similar preparations, asserted in the following:

“The peculiar manner in which the elements are combined is what makes Somnoform at once so efficient and so safe.”

The Council declared Somnoform inadmissible to New and Non­official Remedies because, in the absence of acceptable evidence showing its exceptional safety and value, the claims are unwarranted (Rule 6), and because the name of the mixture is not descriptive of its composition (Rule 8).—(From Reports of Council on Pharmacy and Chemistry, 1919, p. 90.)

TABLETS FORMOTHALATES

Report of the Council on Pharmacy and Chemistry

The Council has authorized publication of the following report which declares Tablets Formothalates (Tailby-Nason Company, Boston, Mass.) ineligible for New and Non­official Remedies.

W. A. Puckner, Secretary.

Tablets Formothalates are sold by Tailby-Nason Company, Boston, Mass. On the label a formula is given: “Constituents: Acetanilid 2 gr.; phenol­phthalein ¹⁄₂ gr. In a balanced combination with Hexamene [a name sometimes applied to hexa­methylen­amin] and Oil of Cinnamon. Indications: Influenza, Colds, Grippe, Headache, Neuralgia, Rheumatism.” The same formula is given in advertisements and in this advertisement it is claimed that they are “For Influenza and Grip” and if “given in the acute stage may avert a serious attack” (Boston M. & S. J., Oct. 3, 1918). The dose is given as one to two tablets at 6 p. m. and repeat at bedtimes.

The A. M. A. Chemical Laboratory reported that the tablets weigh an average of 0.4882 Gm., or 7¹⁄₂ grains; that they have the odor and taste of cinnamon; and that they contain hexa­methylen­amin, are neutral and therefore give up no formaldehyde in the presence of water alone. The Laboratory further reported that they contain phenol­phthalein and acetanilid. These tablets were directed to be taken internally and therefore their effect was not intended to be local.

The amount of hexa­methylen­amin was not determined, but in any case could not exceed 5 grains per tablet. It is evident that 4 grains of acetanilid and 10 grains of hexa­methylen­amin and 1 grain of phenol­phthalein (in two tablets) “if given in the acute stage” of influenza would not “avert a serious attack,” as claimed in the advertisements.

The Council declared Tablets Formothalates inadmissible to New and Non­official Remedies.—(From Reports of Council on Pharmacy and Chemistry, 1919, p. 92.)

TRIPLE ARSENATES WITH NUCLEIN

Report of the Council on Pharmacy and Chemistry

The Council has declared Triple Arsenates with Nuclein No. 1 and Triple Arsenates with Nuclein No. 2, tablets marketed by the Abbott Laboratories, inadmissible to New and Non­official Remedies because unwarranted therapeutic claims (Rule 6) are made for them and because they present an illogical combination of drugs (Rule 10). The publication of the following report has been authorized by the Council.

W. A. Puckner, Secretary.

The following claims are made for Triple Arsenates with Nuclein:

“Puts ‘pep’ and strength back into that patient recovering from Spanish Influenza, pneumonia, typhoid, or surgical operation. An extremely powerful reconstructive tonic. Try it for that ‘run down’ feeling.”

Triple Arsenates with Nuclein is said to contain “Strychnin Arsenate gr. ¹⁄₁₂₈, Quinin Arsenate gr. ¹⁄₆₄, Iron Arsenate gr. ¹⁄₆₄, Nuclein Solution mins. 4.” A second preparation, of double strength—Triple Arsenates with Nuclein No. 2—is also advertised. The Council voted not to accept these preparations for New and Non­official Remedies on the following grounds:

The quantities of quinin, iron and nuclein in the doses represented in these mixtures are negligible; thus, one tablet of Triple Arsenates with Nuclein containing ¹⁄₆₄ grain of quinin arsenate contains only about ¹⁄₉₀ grain of anhydrous quinin; the tablet containing ¹⁄₆₄ grain of iron arsenate contains ¹⁄₂₁₀ grain of iron; 4 minims of the nuclein solution (assuming it to be the “Nuclein Solution-Abbott”) would contain but ²⁄₅ of a grain of nuclein—a substance which even in large doses is of questionable therapeutic value. The amounts of iron and nuclein contained in doses of this preparation are insignificant in comparison with the amounts present in ordinary foods. The only substances present in even small therapeutic doses are strychnin and arsenic. The effects of arsenic and strychnin are very different and there are comparatively few conditions in which they should be prescribed at the same time. Hence a preparation containing these two in fixed proportions is illogical.—(From Reports of Council on Pharmacy and Chemistry, 1919, p. 92.)

“ANTI-PNEUMOCOCCIC OIL” AND THE USE OF CAMPHOR IN PNEUMONIA

Report of the Council on Pharmacy and Chemistry

The Council has adopted and authorized publication of the report which appears below. This report declares “Anti-Pneumo­coccic Oil” (a solution of camphor in oil sold by Eimer and Amend, New York) ineligible for New and Non­official Remedies because (1) the recommendations for its use in pneumonia are not warranted by the evidence, (2) the name is not descriptive of its composition but is thera­peutically suggestive, and (3) the sale of a solution of camphor in oil under a name nondescriptive of its composition is unscientific and a hindrance to therapeutic progress.

W. A. Puckner, Secretary.

The Council having decided to consider Anti-Pneumo­coccic Oil (Eimer and Amend, New York), the preparation was assigned to the Committee on Therapeutics for report. The report that follows was made by a member of this committee:

According to the advertising, Anti-Pneumo­coccic Oil is a “twenty-five per cent. solution of camphor in a thin oil” which was “originated” by August Seibert, M.D. The following directions are given for its use:

“10 c.c. (150 minims) to every 100 pounds of body weight, to be injected hypodermically every eight to twelve hours in pneumo­coccic pneumonia, as soon after the initial chill as possible.”

It is claimed that the prescribed dose one hour before general anesthesia begins, “safeguards against postoperative pneumonia,” and, that “animals can so be immunized against later and otherwise fatal intravenous pneumo­coccic infection (Boehnke, Institute for Experimental Therapy, Frankfort).” The advice is given:

“In pneumo­coccic meningitis, endocarditis and pleuritis, 3% of salicylic acid should be added to this oil.”

In an article by Seibert, “Camphor and Pneumococci” (Medical Record, April 20, 1912), a reprint of which is used to advertise Anti-Pneumo­coccic Oil, previous work (München, med. Wchnschr., No. 36, 1909) is mentioned as the starting point for the use of camphor in pneumonia. In this article, the author reports his first case, that of a young woman who entered St. Francis’ Hospital on the third day after the initial chill “with the symptoms of severe toxemia (unconscious, temperature 105.5 F., pulse 130, and respiration 40) and involvement of both lower lobes.” “Large doses of camphor,” 12 c.c. of a 20 per cent. solution, were injected hypodermically “every twelve hours, resulting in gradual improvement and recovery by the fourth day, without a crisis.” Seibert reports success in its use in twenty-one cases, but gives no case histories or protocols. He admits, however, that in four out of sixteen cases, following the first twenty-one so reported certain “limitations of this treatment were observed,” and a “sudden rise of temperature in two patients on the second and third days of treatment, respectively, proved to be due to pneumo­coccic nephritis, promptly subdued by appropriate doses of urotropin, while the camphor injections were continued and resulting in speedy recovery.” He further admits that empyema occurs, and states: “This proves that the camphor brought into the blood cannot prevent the as yet living organisms, constantly entering the blood current from the affected alveoli, from colonizing in the renal and pleural tissue.”

He reports, among thirty-seven patients treated in this manner, one death, that of a man 68 years old, weighing 200 pounds, with a fatty heart. Heart failure was the real cause of death. Seibert also reports some very incomplete experimental work; Dr. Hensel, assistant and pathologist of the German Hospital, found that “¹⁄_10,000 part of camphor added to the usual culture media inhibited the growth of pneumococci, while the controls all thrived”; Dr. J. C. Welch, pathologist of the Lying-in Hospital, found that rabbits infected with lethal doses of pneumo­coccus cultures intravenously were saved by large doses of camphorated oil; fragmentary protocols are given. The assistant pathologist of St. Francis’ Hospital carried on the experimental work, adding salicylic acid to the camphor. No blood cultures are reported. The conclusion reached by Dr. Seibert is that salicylic acid up to 3 per cent., added to the camphorated oil, is effective in preventing pleural infection. In the article by Dr. Seibert, there appear most sketchy reports of cases, recovery being reported without crisis in from three to nine days.

The referee has made a careful search of the literature, with the following results: Boehnke (Berl. klin. Wchnschr. 50:818, 1913), using white mice, failed to confirm the experiments reported in Seibert’s paper, unless camphorated oil were given before the pneumococci, and even then, he felt that the results were too irregular to be of great significance. When given with anti-pneumo­coccic serum, however, he felt that there was some benefit to be seen by the administration of camphor; his protocols, however, are not detailed. There is no report of blood cultures, etc.

Another worker, H. Leo (Deutsch. med. Wchnschr. 39:690, 1913), reported that camphor water given intravenously prolonged the lives of thirty-eight rabbits inoculated with pneumococci. Here again there were no adequate protocols and very little evidence of careful experimental work appears.

In the literature of the past ten years, there appear sketchy clinical articles on the value of huge doses of camphor in pneumonia. Markevitch (Russk. Vrach, June 27, 1914; abstr., The Journal, Dec. 5, 1914, p. 2081) treated 226 cases of pneumonia with 5 c.c. of camphorated oil hypodermically four times daily, at the same time giving digitalis (amount not stated), with a mortality of 6.6 per cent., whereas, in 322 cases untreated, there was a mortality of 13.3 per cent. He reports 133 grave cases; sixty-six received no camphor; 48 per cent. died. Of sixty-seven treated with camphor, only 22 per cent. died. He reports temperature falling by lysis when camphor is used, and comments on the symptomatic improvement following its use. With the great variation in the clinical course of pneumonia, the above figures, though suggestive, certainly need further support before the routine use of camphor as recommended by Seibert can be sanctioned.

Later articles found on the subject refer to it in a very cursory way, giving no protocols and no cases, and giving the referee the feeling that the conclusions were very impressionistic.

RÉSUMÉ

After a careful search of the literature, the referee concludes that: Huge doses of camphor, to 250 grains in twenty-four hours, may be given to man without serious results. No satisfactory evidence, however, appears that camphor has a specific germicidal action on pneumococci (similar to that of ethyl­hydro­cuprein). The clinical evidence, as found in the literature, is certainly of very little value. It appears that the sale of a simple solution of camphor in oil under the guise of “Anti-Pneumo­coccic Oil” is to be deplored (a 20 per cent. solution of camphor in cottonseed oil is official in the U. S. Pharmacopeia as camphor liniment). It is recommended that the preparation be held inadmissible to New and Non­official Remedies because exaggerated therapeutic claims are advanced for it, and because the name is not descriptive of the composition, but is, instead, thera­peutically suggestive.—(From The Journal A. M. A., Jan. 3, 1920.)

DIAL “CIBA”

Report of the Council on Pharmacy and Chemistry

Dial “Ciba” has not been accepted for “New and Non­official Remedies” because, as the report which follows shows, unwarranted claims are made for the product. It is a definite new chemical compound which might be made eligible for N. N. R. if misleading therapeutic claims were eliminated. The Council directed that Dial “Ciba” be included with Articles Described but Not Accepted, so that physicians might be informed with regard to its character and properties.

W. A. Puckner, Secretary.

Dial “Ciba” is a hypnotic manufactured by the Society of Chemical Industry of Basle, Switzerland, and is sold in the United States by A. Klipstein and Company, Inc., New York. Chemically, Dial “Ciba” is di­allyl­barbituric acid and is, therefore, closely related to di­ethyl­barbituric acid or barbital (“veronal”).

The claims made for Dial “Ciba” are (1), that the “allyl” group in its molecule makes it more readily decomposed by oxidizing agents than barbital, which contains the “ethyl” group; (2) that because of this ease of oxidation, it is more readily decomposed in the body and more rapidly and completely eliminated, and (3) that because of its alleged rapid elimination, it is devoid of the after effects of barbital and other hypnotics.

The Council took up the substance in February, 1918, and referred the matter to the referee in charge of barbital preparations. The referee considered unwarranted the claim that Dial “Ciba” did not have the after-effects of other hypnotics due to its alleged total decomposition in the body. The American agents, A. Klipstein and Company, were informed of the referee’s objections. Their attention was also called to the fact that, notwithstanding the claimed absence of after-effects in one part of the advertising, other parts of the same advertising admitted certain post-hypnotic effects of the product. It was pointed out also that while it was claimed in one of the advertising circulars that lowering of the blood pressure is never observed after administration of Dial “Ciba,” yet two of the authors quoted in the same circular definitely stated that a lowering of the blood pressure followed even small doses of the drug and these authors warn against this very danger in certain conditions.

A year later, a circular letter sent out by A. Klipstein and Company reiterated the claim that the asserted decomposition of Dial “Ciba” in the body prevents after-effects, the drug being still contrasted with barbital (“veronal”). In view of the reiteration of this highly improbable claim, the referee undertook to study the comparative action of Dial “Ciba” as compared with other hypnotics. It was found that the actions of Dial “Ciba” are not distinguishable, qualitatively, from those of barbital, there being no perceptible difference in the after-effects or in the nature of the side actions. In toxic doses, both caused profound depression with the temperature falling to that of the room (or about one degree above), the respiration being extraordinarily slow and shallow as one would expect with lowering of the temperature. There were also the same evidences of nausea that are so frequently seen after toxic doses of the various hypnotics of this group. In view of these results, the Council declared that it is unwarranted to claim freedom from after-effects for Dial “Ciba.”

The Council held that the following statement is unwarranted:

“The therapeutic field for Dial ‘Ciba,’ as shown by tests on rabbits, is just as broad as the field for Di­ethyl­barbituric Acid.”

Tests on rabbits do not and cannot show the breadth of the therapeutic field for a hypnotic. The Council also declared the following statement improbable, and contrary to the evidence obtained by the referee:

“In dogs, the increase of dosage beyond the therapeutic dose to the point of death is decidedly in favor of Dial ‘Ciba,’ which required a larger dose [than di­ethyl­barbituric acid] to produce death.”

The referee’s experiments on cats show that Dial “Ciba” is several times as toxic as hydrated chloral, and more than twice as toxic as di­ethyl­barbituric acid (barbital).

Since the circular to which objection was made in 1918 was still being sent out in December, 1919, the Council held Dial “Ciba” inadmissible to N. N. R. and voted that report of its action in the matter be authorized for publication. The Council further directed that Dial “Ciba” be included with Articles Described but Not Accepted.—(From The Journal A. M. A., Jan. 24, 1920.)

APOTHESINE

Report of the Council on Pharmacy and Chemistry

Apothesine is a synthetic drug for producing local anesthesia, made by Parke, Davis & Company. In the fall of 1917 the Council wrote to Parke, Davis & Company offering its aid in establishing the identity, purity and therapeutic efficiency of this synthetic local anesthetic with the ultimate object of accepting the product for inclusion in New and Non­official Remedies should the facts warrant such acceptance. The Council’s letter was never acknowledged. After Apothesine was put on the market the Council desired to accept it for inclusion in New and Non­official Remedies but, unfortunately, was unable to do so because some of the claims made for the product were not justified by acceptable evidence. The manufacturers were notified of the Council’s desire to admit this product to N. N. R. and the wish was expressed that the company would either so modify its claims as to make the product acceptable under the Council’s rules or else would submit evidence to the Council in proof of the claims made and thus permit the Council to revise its conclusions. Parke, Davis & Company were, apparently, either unwilling or unable to submit evidence that would sustain their claims; neither did they offer to modify the claims themselves. The product, therefore, is ineligible to inclusion in New and Non­official Remedies; it will, however, be listed in the “Described But Not Accepted” department of New and Non­official Remedies. The report on Apothesine that follows has been authorized for publication.

W. A. Puckner, Secretary.

Apothesine, “the hydrochlorid of diethyl-amino-propyl-cinnamate,” is an efficient local anesthetic. It belongs to the procain rather than to the cocain type, that is, it belongs to that type which, while effective for injection anesthesia (especially when combined with epinephrin) is relatively inefficient when applied to mucous membranes. Apothesine may also be used for spinal anesthesia. Its absolute toxicity is less than that of cocain (as 20 is to 15, see table below) but about twice that of procain (as 20 is to 40, see table below). It is non-irritant, is easily soluble and makes a stable solution so that it may readily be sterilized.

The Council took exception to certain claims made by Parke, Davis & Company for their product on the ground that these claims were not supported by acceptable scientific evidence. One of the claims was that Apothesine is applicable in any case in which any other local anesthetic is used. This statement, made in many advertisements, is distinctly misleading as used. When applied to mucous membranes Apothesine is far inferior to cocain and to some other local anesthetics, yet the claim obviously suggests that Apothesine is an efficient substitute for any local anesthetic.

The manufacturers claimed, too, that Apothesine is as potent as cocain. The claim would lead the physician to think that Apothesine had the same anesthetic potency as cocain in solution of equal strength. This statement, so far as it refers to the drug when applied to mucous membranes, is not in accord with the facts and is true for injection anesthesia only when stronger solutions are used. The only support for the claim of equal efficiency appears to be the experiments with intracutaneous injections made by H. C. Hamilton130 in Parke, Davis & Company’s laboratory. These differed considerably from the results of Sollmann.131 A further series of experiments were made by Sollmann to compare still further the diverse results previously reported by him and Hamilton. The latest series, while showing considerable variations in the susceptibility of different skin areas, especially toward Apothesine, demonstrated in every case that the efficiency of Apothesine is unmistakably lower than that of cocain, being at best one half. The series also showed that the potency of Apothesine was never greater than procain and averaged considerably below it.

Another claim made for Apothesine which the Council holds is not supported by evidence is that of superior safety. This claim is made on the basis of hypodermic injections in guinea-pigs carried out in the laboratory of Parke, Davis & Company. Such experiments prove little because of the fact—well known to laboratory workers—that the use of rodents in toxicity tests made by injecting a drug into the subcutaneous tissues does not give a reliable index of the relative toxicity of such a drug for man. This is due partly to the peculiar resistance of rodents to poisons and partly to the great importance of the rate of absorption. The organism destroys most local anesthetics so rapidly that the rate of absorption is more important than the absolute dose. The absorption from hypodermic injections into guinea-pigs differs, of course, from that in clinical accidents, especially where the drug has been applied to mucous membranes. One cannot, therefore, reliably estimate the degree of clinical danger on animals.

It has been shown that when toxicity tests of local anesthetics are made on cats these animals seem to respond to the drugs in a manner more closely approximating humans and it is a suggestive fact that the more toxic of local anesthetics, as shown by tests on cats, have been found the most dangerous in clinical use. The absolute toxicity of Apothesine has been measured by Eggleston and Hatcher132 by the intravenous injection in cats. The fatal doses, in terms of milligrams per kilogram ranged as follows:

Alypin, Holocain10

Beta Eucain12.5

Cocain15

Apothesine20

Tropacocain20–25

Stovain25–30

Nirvanin30–35

Procain40–45

The absolute toxicity of Apothesine is, therefore, only a little lower than that of cocain, and is twice as great as that of procain. The clinical dangers cannot be predicted by either method, since clinical accidents depend, in most instances, on idiosyncrasies, or the technic of application.—(From The Journal A. M. A., Jan. 24, 1920.)

EUMICTINE

Report of the Council on Pharmacy and Chemistry

The Council has adopted and authorized publication of the report which appears below. This report declares “Eumictine” ineligible for New and Non­official Remedies because (1) it conflicts with Rule 10 in that it is unscientific, (2) it conflicts with Rule 6 in that it is sold under unwarranted therapeutic claims, (3) it conflicts with Rule 4 against indirect advertising to the public in that the name “Eumictine” is blown in the bottle for the obvious purpose of bringing the product to the attention of the public when it is prescribed in the original package, and (4) because the name is thera­peutically suggestive and not in any way descriptive of its composition.

W. A. Puckner, Secretary.

Eumictine is a preparation from the laboratory of Maurice Le Prince, Paris, France, and is marketed in this country by George J. Wallau, Inc., New York. It is claimed that the product is “a balsamo-antiseptic preparation composed of Santalol, Salol, and Hexamethylene-Tetramine, in the form of gluten-coated capsules.” Nowhere in the advertising are the amounts of the ingredients given. According to the American agent, however, “each capsule is supposed to contain 20 centigrams of Santalol, 5 centigrams of Salol, 5 centigrams of Hexamethylene-Tetramine.”

Eumictine is advised “in treating genito-urinary diseases (urethritis, cystitis, prostatitis, pyelitis, etc.).” It is claimed to be “both an antiphlogistic modifying agent, a well-tolerated diuretic” which “may be administered for long periods without ill effects.”

The Council declares Eumictine ineligible for New and Non­official Remedies because it is exploited in conflict with the following rules:

It is unscientific (Rule 10). Eumictine is composed of hexa­methylen­amin, salol and sanalol in fixed proportions. Hexamethylenamin may serve a useful purpose in some forms of infection of the urinary tract, but neither it nor salol is of any considerable value in gonorrhea. It is now known that the balsamic preparations, formerly so widely used, do not have the curative effects in gonorrhea and associated conditions that used to be ascribed to them. To combine three substances, none of which has any distinct therapeutic value in the conditions for which Eumictine is proposed, does not enhance their value. There is nothing original in the combination used in Eumictine, or in the manner of dispensing it.

It is sold under unwarranted therapeutic claims (Rule 6). These claims are made not only for the components of Eumictine but for the combination itself. Though santalol has certain advantages over the somewhat variable oil of santal and other balsamic resins, it is not true that santalol “does not cause congestion of the renal epithelium” or that it does not “produce exanthema as do copaiba, cubebs, and the ordinary santal oil.” It is not true that salol is “devoid of toxicity.” Neither is it correct to say that salol “asepticizes and disinfects the bladder, the prostate and the urethra.” The claim that hexa­methylen­amin “is of value when any acute symptoms or tendency to inflammation subsist” is not justified. The claim that hexa­methylen­amin “renders soluble the uric acid and urates” is also without foundation. The following paragraph is characteristic of the claims made for Eumictine:

“Anti-gonorrhoic by its Santalol, diuretic, urolytic and analgetic by its hexa­methylene­tetramin (Urotropin) antiseptic and antipyretic by its Salol, Eumictine represents a real therapeutic advance in the scientific treatment of diseases of the urinary passages.”

Instead of being “a real therapeutic advance” in the treatment of diseases of the urinary passages, Eumictine presents one of the complex combinations that have long retarded the scientific treatment of these diseases. Eumictine also conflicts with Rules 4 and 8 of the Council.—(From The Journal A. M. A. Feb. 21, 1920.)

PLATT’S CHLORIDES

Report of the Council on Pharmacy and Chemistry

The Council has authorized publication of the following report on “Platt’s Chlorides.” It also declares the preparation inadmissible to New and Non­official Remedies because its composition is uncertain and indefinite and because the claims made for it are exaggerated and misleading.

W. A. Puckner, Secretary

“Platt’s Chlorides,” marketed by Henry B. Platt, New York, is sold as a disinfectant and germicide. Only incomplete and contradictory statements have been made in regard to its composition. Many years ago (about 1899) the composition of Platt’s Chlorides was given as “The Chlorids of Zn 40 per cent., Pb 20, Ca 15, Al 15, Mg 5, K 5.” The statement that the preparation contained 20 per cent. of lead chlorid is interesting, in view of the fact that lead chlorid is soluble in water at ordinary temperatures to the extent of less than 1 per cent. In a booklet, also issued a number of years ago, the following “Formula of Platt’s Chlorides” was given:

“A saturated solution of Metallic Chlorids combined in the following proportions:

“Sol. Zinc Chlorid40 per cent.

“Sol. Aluminum Chlorid15 per cent.

“Sol. Lead Chlorid20 per cent.

“Sol. Calcium Chlorid15 per cent.

“Sol. Magnesium Chlorid 5 per cent.

“Sol. Potassium Chlorid 5 per cent.”

The label on a bottle purchased in 1911, describes Platt’s Chlorides as:

“A Highly Concentrated Solution of the Chlorids of Aluminum, Calcium, Lead, Zinc, etc.”

The label of a bottle purchased in 1919 reads:

“Contains Inert Material: Water 84.0%. Sodium Chlorid 4.8%. Calcium Chlorid 0.3%.”

This statement is obviously made to meet the requirements of the federal Insecticide Act. This law requires either that the identity and the amounts of potent ingredients in disinfecting preparations be declared or else that the percentage of the inert ingredients of such preparations be given. The omission from the label of all statements with regard to the potent ingredients of the preparation and the absence of such a statement in recent advertising matter suggests either that the older statements about its composition were false or else that the composition has been changed.

Tscheppe published (Pharmaceutische Rundschau 8:109, 1890) an analysis of Platt’s Chlorides which has been quoted in other publications as indicating the composition of the preparation. He reported that he found each quart of the preparation to contain aluminum sulphate 6 ounces, zinc chlorid 1¹⁄₃ ounces, sodium chlorid 2 ounces, calcium chlorid 3 ounces.

Some years ago (about 1911) the company made the following statement relative to the germicidal power (phenol co-efficient) of Platt’s Chlorides:

“... for some time the carbolic acid co-efficiency of our output has been from 2.5 to 4.3, the average being about 3; namely about three times stronger than pure carbolic acid.”

In 1912, the U. S. Public Health and Marine Hospital Service reported (Bulletin 82, Public Health and Marine Hospital Service, p. 69) that the phenol coefficient of a sample of Platt’s Chlorides was so low that it could not be determined and also that the sample was found to contain some mercuric chlorid. In 1913, the North Dakota Agricultural Experiment Station reported (Bulletin, July, 1913, p. 292), that Platt’s Chlorides contained principally zinc chlorid, also some aluminum chlorid, calcium chlorid, and traces of mercuric chlorid. The phenol coefficient, determined by the Hygienic Laboratory method, was found to be 0.05.

The preceding suggests that the composition of Platt’s Chlorides had been changed (without notice to the consumer) and that it had been fortified by the addition of mercuric chlorid. Years ago part of the advertising of this product was a testimonial from a health official which declared that, for disinfection, “bichlorid of mercury is useless in disinfecting sputum or discharges from the bowels, being rendered inert by the albumin present” and it lauded Platt’s Chlorides as devoid of such drawbacks.

RECENT ANALYSES OF PLATT’S CHLORIDES

To determine the present composition of Platt’s Chlorides and to compare it with that sold formerly, the A. M. A. Chemical Laboratory has made an analysis of a specimen purchased in 1919 and also of one purchased in 1911 and since kept unopened in the files of the Council on Pharmacy and Chemistry. The following table contains the results of these analyses (all quantities given are Gm. per 100 c.c.):

1911 Specimen 1919 Specimen

Color ColorlessStraw Color

Odor None None

Specific Gravity at 25 Cc. 1.1229 1.1313

Total Solids (residue at 100 Cc.)16.4918.33

Chlorid (Cl^-) 7.6010.74

Sulphate (SO₄^{- -}) 1.11 .16

Aluminum (Al⁺⁺⁺) .22 .90

Calcium (Ca⁺⁺) .19 .13

Zinc (Zn⁺⁺) 5.11 3.93

Lead (Pb⁺⁺) .046Traces

Mercury (Hg⁺⁺) ....... .0086

Sodium (Na⁺) 1.01 1.39

These quantities transposed to hypothetical combinations would indicate that Platt’s Chlorides has the following composition:

1911 Specimen 1919 Specimen

Aluminum Sulphate 1.32 .18

Aluminum Chlorid .074.29

Calcium Chlorid .54 .37

Zinc Chlorid10.668.19

Lead Chlorid .06Traces

Mercury Chlorid ....... .0116

Sodium Chlorid 2.574.81

Hydrogen Chlorid .43 None

In the past, the advertising has suggested, more or less directly, that, as chlorinated lime (bleaching powder) may be made to give off chlorin gas which disinfects, so the air in a room may be disinfected by evaporating Platt’s Chlorides. Thus the label of the 1911 specimen contains the following:

“For Store Rooms, Refrigerators, and Closets, keep a sponge saturated with the pure liquid in a saucer on an upper shelf.”

On the label of the 1919 specimen, the statement reads:

“Refrigerators and Storerooms—As a disinfectant wash regularly with one part Chlorides to eight of water. As a deodorant, keep in an open vessel a sponge or cloth saturated with the Chlorides full strength.”

That the owner of Platt’s Chlorides really believes that the vapors of the preparation have disinfecting properties is seen from a letter over the name of Henry B. Platt printed in the New York Tribune in 1916. This read, in part:

“... by keeping in a dish or saucer on radiators Platt’s Chlorides diluted one-half, the hot solution will evaporate and purify the air, thus destroying the grip germ which is the cause of all the trouble.”

From the analysis of Platt’s Chlorides, it is evident that when the preparation is evaporated, water vapor only escapes.133 Whatever disinfecting or germicidal action the preparation may possess is exercised only when the solution is brought in direct contact with the substance to be disinfected.

The aluminum and zinc salts present may be useful as deodorants but they are not effective as germicides. The presence of mercuric chlorid in a concentration of 1 to 10,000 is hardly to be considered as materially increasing the efficiency. The directions recommend the use of a mixture of 1 part of Platt’s Chlorides to 10 parts of water for rinsing the hands, and a mixture of 1 part to 4 parts of water for the disinfection of discharges. It is further stated that 1 quart makes 2 gallons sufficiently strong for general use. It is evident that such dilutions decrease considerably the feeble germicidal action of the original fluid.—(From The Journal A. M. A., March 27, 1920.)

ANTI-TUBERCULOUS LYMPH COMPOUND (SWEENY) AND ANTI-SYPHILITIC COMPOUND (SWEENY)

Report of the Council on Pharmacy and Chemistry

The Council has authorized publication of the reports which appear below, declaring Anti-Tuberculous Lymph Compound (Sweeny) and Anti-Syphilitic Compound (Sweeny) ineligible for New and Non­official Remedies.

W. A. Puckner, Secretary.

Anti-Tuberculous Lymph Compound (Sweeny)

“Anti-Tuberculous Lymph Compound (Sweeny)” is put out by the National Laboratories of Pittsburgh, Dr. Gilliford B. Sweeny, “Medical Director.” Sweeny has claimed at different times that he became interested in the subject of von Behring’s efforts to immunize cattle to tuberculosis at a time when he was an assistant in von Behring’s laboratory. He claims to have conceived the idea while there of transferring bovine immunity to tuberculosis to the human subject and later to have evolved his “treatment” at the Pasteur Institute in Paris.

Just how Anti-Tuberculous Lymph Compound is made today is not stated—at least so far as one is able to learn from recent advertising. Some years ago Sweeny declared that his “Anti-Tubercular Lymph” (as it was then called) was derived from a bullock which had been immunized to tuberculosis. Then:

“The immunized animal having been slaughtered, the contents of the lymph reservoirs are carefully collected and an aqueous extract is made from the grey cerebral substance, spinal cord and the lymph glands. It is then filtered under high pressure and de-albuminized by succussion. To this, the lymph, together with a definite proportion (50 per cent.), of the naturally phosphorized brain fats is added, with a small amount of chloride of gold (about 1-60 gr. to the dose), the latter as a preservative.”

It is a fair assumption that however the preparation may have been made originally, it is not now made in such a manner as to bring it under the federal laws governing the preparation of serums and similar preparations. The claims made for Anti-Tuberculous Lymph Compound are of the usual uncritical and unscientific type. Mainly, of course, they are of the testimonial class. The physician is told that the preparation has been carefully tested by men whose judgment is worthy of consideration; that the verdict has been altogether favorable to the “Compound.” Thus:

“... the remedy was submitted to a selected body of skilled physicians, recognized for their skill and care in making therapeutic observations. These men represented widely varying conditions, climatic and otherwise. Those who said ten years ago that Anti-Tuberculous Lymph Compound has a specific immunizing influence upon the tuberculosis patient, find the same to be true today.”

Careful reading of the matter just quoted will reveal its ambiguity and inherent lack of frankness. The inference conveyed is that the “selected body of skilled physicians” have unqualifiedly endorsed Anti-Tuberculous Lymph Compound (Sweeny)—but it does not say so!

It is the history of all such preparations, introduced to the medical profession with the usual blare of trumpets, that a certain number of favorable testimonials can be obtained. It is also the history of such products that one has but to wait a few years and the physicians who had written most enthusiastically regarding the preparation—in the first flush of their optimism following its use and the perusal of the manufacturers’ literature—will acknowledge that they were mistaken in their original estimate and are no longer using the agent. In this connection an investigation of some of the old testimonials for Anti-Tuberculous Lymph Compound by the Propaganda department of The Journal is instructive.

In a somewhat elaborate booklet published in 1907 by Sweeny, an Indiana physician was said to have reported favorable results following the administration of the “lymph.” A letter written to this physician in October, 1919, asking for his present opinion on the product brought this reply, in part:

“... it being twelve years since using the serum and no reference or repeated orders since should surely suffice as evidence of my lack of faith in the serum....”

An Illinois physician was reported in the same booklet to have described a case of a young man with an active tuberculosis, who was given injections of the “lymph” in February, 1907. The patient, it was claimed, showed immediate improvement and the Sweeny booklet (published in August, 1907) stated that “improvement in this case continued and terminated in complete recovery.” A letter written to the physician in October, 1919, brought out the fact that the young man in question, after receiving “Anti-Tuberculous Lymph Compound” and other treatment was removed “on a stretcher” “to New Mexico, where he remained for three or four years” and recovered. The doctor adds:

“I do not think that the Anti-Tuberculous Lymph had anything to do with the man’s recovery, although I realize the difficulty of definitely analyzing just what did effect the cure. I did since that time use that preparation in several other cases without beneficial results so that I gave it up a good many years ago adding it to that large heap of pharmaceutical material ‘weighed and found wanting.’ ”

A physician in Texas also reported in the 1907 booklet as having had very satisfactory results with the Anti-Tuberculous Lymph Compound in one case of pulmonary tuberculosis was written to in October, 1919. He replied:

“I will state that subsequent use of this compound did not bear out the apparent good results from its use in the first case or two.”

In a “Bulletin” issued by the Sweeny concern in 1912, a Pennsylvania physician was quoted as having treated three cases with Anti-Tuberculin Lymph Compound with resultant cures. This physician was written to in October, 1919, and he replied:

“I have no knowledge of the use of my name by any Pittsburgh concern and know nothing of a lymph of the name of Sweeny; neither do I recollect ever curing three cases of tuberculosis with any lymph.”

The same “Bulletin” quoted the alleged statement by a Delaware physician to the effect that he believed Anti-Tuberculous Lymph Compound to be the most successful treatment of tuberculosis extant. This in 1912. To an inquiry sent in October, 1919, this physician briefly replied:

“Am not using it now.”

The result of the Propaganda department’s questionnaire was what might have been expected. Every physician who answered the inquiry regarding his previous and present opinions of Anti-Tuberculous Lymph Compound (Sweeny) declared, in effect, that he had long since ceased to have faith in its value or efficacy.

According to claims made in Sweeny literature, “Anti-Tuberculous Lymph Compound exercises its immunizing power through a specific action upon the blood cells.” The statement that “it destroys the tuberculosis germ when this is present in the system of the patient” is untrue. The facts are, no serum or lymph has thus far been proved to have any value in the treatment of tuberculosis even when fortified by “a small proportion of chloride of gold and soda” as one circular tells us the “lymph” is. In spite of research by competent investigators, we are still without any aid in the form of a serum in the treatment of tuberculosis.

Anti-Tuberculous Lymph Compound (Sweeny) is one of those preparations that need no elaborate laboratory tests, nor even exact therapeutic research, to convince any clear-thinking person that it is patently and obviously worthless. One would hesitate before asking any reputable clinician to test a preparation of this sort. It is a constant source of surprise that some physicians allow themselves to be persuaded by advertising literature that is obviously uncritical and unscientific, to use preparations which have no more reasonable foundation than this one.

The Council declares Anti-Tuberculous Lymph Compound (Sweeny) not acceptable for New and Non­official Remedies.

Anti-Syphilitic Compound (Sweeny)

This preparation also is made by or under the direction of the same Dr. Gilliford B. Sweeny whose researches (?) led to the production and evolution of the Anti-Tuberculous Lymph Compound (Sweeny). According to the data at hand, this preparation is made by suspending benzoate of mercury in lymph from the bullock. Case reports are given of alleged cures of syphilis after two months of treatment; indeed, the circular exploiting the agent makes the statement that it is seldom necessary to continue the treatment beyond two months, which, if one chose to be credulous, would indicate extraordinary power for the mercury.

Mercury of course has a proper place in the treatment of syphilis, but that any physician could be induced to place his trust in this preparation is almost unthinkable though testimonials—which the “National Laboratories” claim to have received from physicians—are published. They all stamp the writers as not only gullible but also incompetent. The tenor of the claims is on a par with those made for the Anti-Tuberculous Lymph Compound; they do not justify the time required for detailed consideration.

The Council declares Anti-Syphilitic Lymph Compound (Sweeny) not acceptable for N. N. R.—(From The Journal A. M. A., April 3, 1920.)

SYRUP LEPTINOL (FORMERLY SYRUP BALSAMEA)

Report of the Council on Pharmacy and Chemistry

The Council has authorized publication of the following report on “Syrup Leptinol” (formerly “Syrup Balsamea”). The product is inadmissible to “New and Non­official Remedies,” first, because the manufacturers fail to give the profession information regarding either the amount of the potent ingredient or the method of determining its identity and uniformity; second, because of the unwarranted recommendation for its use in such infectious diseases as pneumonia and epidemic influenza and for lack of satisfactory supporting evidence of its alleged therapeutic efficacy in other diseases and, third, because the recommendations for its use appearing on and in the trade package constitute an indirect advertisement to the public.

W. A. Puckner, Secretary.

Syrup Leptinol is sold by the Balsamea Co. of San Francisco. It was first introduced as Syrup Balsamea. In recent advertising, Syrup Leptinol is also referred to simply as “Leptinol.”

According to the statements of the Balsamea Co., Syrup Leptinol is prepared from the root of a species of Leptotaenia (a plant belonging to the parsnip family) which grows in Nevada and which has heretofore not been used in medicine. The manufacturer states that the botanists who have been consulted have been unable to agree on the botanical classification of the plant. The dried root of this unclassified species of Leptotaenia is extracted with alcohol and from the extract so obtained the syrup is made, but no information has been furnished to show how the alcohol-soluble material is incorporated in the syrup. Further, the manufacturer has not announced tests whereby the identity and uniformity of the finished preparation may be determined.

A booklet contains the following:

“The species of Leptotaenia from which Leptinol is produced was first used in medicine by Dr. E. T. Krebs, who, after thorough laboratory investigation and clinical application over a period of several months, which resulted in the perfecting of Leptinol, prescribed the preparation for Influenza during the epidemic of that disease in 1918 with remarkably good results. Since this first use, Leptinol has been exhaustively tested by clinicians in private practice and in hospitals in the treatment of Pneumonia, Influenza Bronchitis, etc., and has been universally endorsed.”

In a circular letter it is asserted that the use of “Leptinol” during the “influenza epidemic” of 1918–1919 “demonstrated its almost specific action in respiratory affections”; that “during this epidemic it proved to be five times as efficacious as any other treatment in pneumonia ...”; and that “it is now as firmly fixed in the mind of many doctors for respiratory diseases as quinine is for malaria and the salicylates for rheumatism.”

In the booklet it is further stated that the therapeutic action of the preparation is primarily that of a “stimulating expectorant” and secondarily as a “sedative expectorant”; that “its antiseptic action in the respiratory tract is prompt”; that it “is an effectual cardiac tonic where the tone of the heart muscle is impaired by fever”; that “in acute pulmonary conditions it effectively improves the respiratory action and allays cerebral irritation due to fever and toxins”; that it acts “as a vital stimulant and nerve sedative”; that “it stimulates the excretion of acid by the skin and in fever it has a strongly diaphoretic and antipyretic action without depressing the circulation or the central nervous system”; that it is “mildly diuretic” and “slightly augments the biliary flow” and that “it increases the gastric and intestinal secretions and allays intestinal fermentation.”

No evidence has been presented to the Council which shows that Syrup Leptinol has the actions ascribed to it. The reports of clinical trial are little more than chance observations and lack all control. This applies also to the following, stated to be a quotation from the report of the Tonopah Mines Hospital Association:

“In the spring of 1919 a recurrence of the Influenza epidemic of the previous winter was experienced. During the first period of this second epidemic, prior to April 15th, there were treated one hundred sixteen cases of Influenza, fourteen of which developed Influenzal Pneumonia, with six deaths. The Pneumonia was of the very virulent type which prevails in this high altitude.... After April 15th, when the clinical use of Leptinol was inaugurated, three hundred and sixty-eight cases of Influenza were treated and not a single case developed Pneumonia. Twenty-two cases of Influenzal Pneumonia were received and treated with Leptinol, with a consequent one hundred per cent. recovery....

“In the cases where Leptinol was used the treatment was the same as had been previously followed, as to diet, fresh air, etc., but the medication was confined to Leptinol. Syrup Leptinol was started immediately in one-dram doses at one-hour intervals, in cases with high temperatures, and this was continued until temperature and pulse subsided. It was then used in one-dram doses at three-hour intervals as recovery progressed. On admission to the hospital, calomel in ¹⁄₄ grain doses, was given at fifteen minute intervals for eight doses. The last calomel was followed in six hours by ¹⁄₂ ounce Magnesium Sulphate in saturated solution. The second day ¹⁄₁₀ grain of calomel was given at one-hour intervals for ten doses....”

Medical journals are replete with reports of remarkable results obtained with the most varied forms of treatment instituted at the time that the “influenza epidemic” had been reached. In these cases it is more than probable that the lessened virulence of the causative factor of the disease, the gradually established resistance of those stricken with it in the latter period and the improved management resulting from experience deserve the credit for the successful outcome of the treatment, rather than the particular form of medication employed.

The report of the Tonopah Mines Hospital Association directly implies that Syrup Leptinol prevents the development of pneumonia in practically all cases of influenza in which it would develop and that it entirely abolishes the mortality of that disease. However, it is well known that innumerable remedies have been recommended as specifics in the treatment of pneumonia on the basis of the treatment of a limited number of cases which recovered, and that eventually these asserted specifics have been discarded as of little value. In the present instance, the recovery of twenty-two cases in succession afford prima facie evidence that those cases were not the virulent type of pneumonia in which the death rate is very high under any methods of treatment. While no effort appears to have been made to determine the nature of the infecting organism, the records show fairly conclusively that they belonged to those causing the milder type of pneumonia.

The Council finds Syrup Leptinol (formerly Syrup Balsamea) inadmissible to New and Non­official Remedies because: (1) the information in regard to composition does not state the amount of potent ingredient, nor permit the determination of its identity and uniformity; (2) the recommendation for its use in such infectious diseases as pneumonia and epidemic influenza is unwarranted and its claimed therapeutic efficacy in other diseases is without satisfactory supporting evidence; and (3) the recommendations for its use which appear on the label and the circular wrapped with the trade package constitute an indirect advertisement to the public.

The Council accepts the explanation of the manufacturer that he has been unable to obtain a satisfactory classification of the plant from which Syrup Leptinol is made. It would be undesirable to exclude from therapeutic use a valuable drug simply because its botanical character has not been determined or because an exhaustive chemical examination had so far not been made. However, in the absence of such information the manufacturer should give full information with regard to the preparation or standard­ization of his remedy and the therapeutic claims made for it should be accompanied by indisputable, thoroughly controlled clinical evidence. In the case of Syrup Leptinol, there is no satisfactory evidence available showing that the preparation has any value in the treatment of epidemic influenza, pneumonia, whooping cough, etc. While it is probable that a balsamic syrup, such as Syrup Leptinol, has palliative properties in coughs, such action does not at all justify the claim that it is useful in the contagious diseases for which it is proposed. The Council cannot recognize a syrup presenting an unknown plant in uncertain proportions which is recommended in a variety of dangerous contagious diseases in which it ultimately may be harmful, even though in early stages of these diseases it may serve to allay some of the milder symptoms.